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Hyphen BioMed recalls ZYMUTEST HIA MonoStria qualitative screening assay intended for the global detection of heparin-dependent antibodies, wh
Recalled May 16, 2018 · FDA recall Z-1743-2018 · Hyphen BioMed
Hazard
Incorrect package insert indicating use of the kits with plasma, serum, and other biological fluids. The kits should only be used with plasma. · FDA Class II
Units
60
Sold at
OH, MD, NC, NY, NH, Canada, Sweden
Description
Incorrect package insert indicating use of the kits with plasma, serum, and other biological fluids. The kits should only be used with plasma.
Product
ZYMUTEST HIA MonoStria qualitative screening assay intended for the global detection of heparin-dependent antibodies, whether the isotype is: IgG, IgM and IgA, in human plasma, by clinical laboratories. p IgGAM; REF Number: RK041D; UDI: 03663537046810
Manufacturer(s)
Hyphen BioMed
Made in
France
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →